Department of Cardiology and Vascular Medicine, West German Heart and Vascular Centre Essen, University Hospital Essen, Germany.
Universitätsklinikum Freiburg Herzzentrum, Bad Krozingen, Germany.
Eur J Vasc Endovasc Surg. 2024 Jun;67(6):923-932. doi: 10.1016/j.ejvs.2024.02.043. Epub 2024 Mar 4.
There is a need for improved outcomes in the endovascular treatment of patients suffering from chronic limb threatening ischaemia (CLTI), highly calcified lesions, and chronic total occlusions (CTOs). The helical centreline self expanding BioMimics 3D stent might be particularly useful in these high risk subsets, combining flexibility and fracture resistance with radial strength. Herein, the performance of the BioMimics 3D stent was assessed in these high risk subsets.
MIMICS-3D is a prospective, multicentre, European real world registry. This was a post hoc analysis, comparing patients with CLTI vs. intermittent claudication (IC), lesions with bilateral calcification vs. those without (peripheral arterial calcium scoring system [PACSS] 3,4 vs. PACSS 0 - 2), and CTO vs. no CTO. Propensity score matching was performed to reduce the impact of baseline variables. The 36 month endpoints were clinically driven target lesion revascularisation (CD-TLR), death, major target limb amputation, and stent patency.
A total of 507 patients were enrolled. At 36 months, patients with CLTI had lower freedom from major amputation than patients with IC (92.6% vs. 100%, p < .001). In terms of primary patency, patients with CTO had lower patency rates than those without (63.9% vs. 77.8%, p = .003), but the difference reduced after propensity score matching (70.5% vs. 76.8%, p = .43). Primary patency was not impaired for patients with PACSS 3,4 or patients with CLTI. Freedom from CD-TLR was not significantly different among the groups and was 73.8% for CLTI vs. 78.9% for IC (p = .15), 77.6% for PACSS 3,4 vs. 78.7% for PACSS 0 - 2 (p = .55), and 75.6% for CTO vs. 81.0% for no CTO (p = .11).
The outcome of the MIMICS-3D registry suggests that the BioMimics 3D stent is effective in the endovascular treatment of complex femoropopliteal lesions and in CLTI. Future randomised controlled trials should confirm its non-inferiority or superiority compared with existing alternatives.
在治疗患有慢性肢体威胁性缺血（CLTI）、高度钙化病变和慢性完全闭塞（CTO）的患者时，需要改善血管内治疗的效果。螺旋中心线自膨式 BioMimics 3D 支架在这些高危亚组中可能特别有用，它结合了柔韧性和抗断裂性以及径向强度。在此，评估了 BioMimics 3D 支架在这些高危亚组中的性能。
MIMICS-3D 是一项前瞻性、多中心、欧洲真实世界注册研究。这是一项事后分析，比较了 CLTI 患者与间歇性跛行（IC）患者、双侧钙化病变患者与无钙化病变患者（外周动脉钙评分系统[PACSS]3、4 与 PACSS 0-2）、CTO 患者与无 CTO 患者。采用倾向评分匹配来降低基线变量的影响。36 个月的终点是临床驱动的靶病变血运重建（CD-TLR）、死亡、主要靶肢体截肢和支架通畅率。
共纳入 507 例患者。36 个月时，CLTI 患者的主要截肢免于率低于 IC 患者（92.6%比 100%，p<.001）。在原发性通畅率方面，CTO 患者的通畅率低于无 CTO 患者（63.9%比 77.8%，p=.003），但倾向评分匹配后差异缩小（70.5%比 76.8%，p=.43）。PACSS 3、4 患者或 CLTI 患者的原发性通畅率不受影响。各组之间 CD-TLR 免于率无显著差异，CLTI 为 73.8%，IC 为 78.9%（p=.15），PACSS 3、4 为 77.6%，PACSS 0-2 为 78.7%（p=.55），CTO 为 75.6%，无 CTO 为 81.0%（p=.11）。
MIMICS-3D 注册研究的结果表明，BioMimics 3D 支架在治疗复杂股腘病变和 CLTI 方面是有效的。未来的随机对照试验应证实其与现有替代方法相比的非劣效性或优越性。
